Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pin, Fixation, Threaded
510(k) Number K132820
Device Name VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
Applicant
Vilex, Inc.
7214 Lake Forest Glen
Lakewood Ranch,  FL  34202
Applicant Contact ABRAHAM LAVI
Correspondent
Vilex, Inc.
7214 Lake Forest Glen
Lakewood Ranch,  FL  34202
Correspondent Contact ABRAHAM LAVI
Regulation Number888.3040
Classification Product Code
JDW  
Date Received09/09/2013
Decision Date 07/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-